Modular interbody spacer

ABSTRACT

An intervertebral spinal spacer system includes a first portion of a modular spacer, the first portion having an upper surface, a lower surface, and an outer surface, and a second portion of the modular spacer, the second portion having an upper surface a lower surface, and an outer surface. The first portion is selectively engageable with the second portion. The first portion and the second portion each define an internal cavity extending from the respective upper surface to the respective lower surface.

REFERENCE TO RELATED APPLICATION

The present application is a continuation of U.S. non-provisional patentapplication Ser. No. 16/691,733, filed Nov. 22, 2019, which is acontinuation of U.S. non-provisional patent application Ser. No.16/035,485, filed Jul. 13, 2018, which is a continuation of U.S.non-provisional patent application Ser. No. 15/612,817, filed on Jun. 2,2017, now U.S. Pat. No. 10,034,766, which is a continuation of U.S.non-provisional patent application Ser. No. 15/050,160, filed on Feb.22, 2016, now U.S. Pat. No. 9,693,875, which is a continuation of U.S.non-provisional patent application Ser. No. 13/967,115, filed Aug. 14,2013, now U.S. Pat. No. 9,295,561, which claims the priority benefit ofU.S. provisional patent application Ser. No. 61/682,917, filed Aug. 14,2012, and hereby incorporates the same applications herein by referencein their entirety.

TECHNICAL FIELD

An interbody spacer is provided and, more particularly, an interbodyspacer having fluid passages to facilitate the flow of bone marrow andblood elements rich in mesenchymal or undifferentiated hematologic cellsand growth factors.

BACKGROUND

Human intervertebral discs generally serve two functions, they cushionand allow movement between pairs of vertebrae. Cushioning is performedby a gel-like material, which forms the inner part of the discs. Afibrous outer layer surrounds the inner gel-like material. Discs aresubjected to a great many strains and stresses and are known todeteriorate with age, injury, or disease. When discs are damaged ordiseased, the mobility of the subject is often impaired and great painmay result from movement. Damaged discs may also place pressure on thespinal column, causing pain.

SUMMARY

Embodiments of an interbody spacer described herein can include anintervertebral spinal spacer that can include a substantially annularbody having an upper surface, a lower surface, an outer surface, and aninner surface, where the inner surface of the substantially annular bodycan define an internal cavity. The spinal spacer can include a pluralityof outer apertures, where the plurality of outer apertures can bedefined by the upper surface or the lower surface of the substantiallyannular body. The spinal spacer can include a plurality of innerapertures, where the plurality of inner apertures can be defined by theinner surface of the substantially annular body. The spinal spacer caninclude a plurality of fluid passages that can be defined by thesubstantially annular body and can connect each respective outeraperture to a corresponding inner aperture, where each fluid passage canbe configured such that fluid can communicate from the plurality ofouter passages, through the plurality of fluid passages, and into theinternal cavity of the substantially annular body.

Embodiments of an interbody spacer can include a zero profileintervertebral spinal spacer that can include a substantially annularbody that can have an upper surface, a lower surface, an outer surface,and an inner surface, where the inner surface of the substantiallyannular body can define an internal cavity, where the substantiallyannular body can include a first modular portion and a second modularportion. The spinal spacer can include a plurality of outer apertures,where the plurality of outer apertures can be defined by the uppersurface and the lower surface of the substantially annular body. Thespinal spacer can include a plurality of inner apertures, where theplurality of inner apertures can be defined by the inner surface of thesubstantially annular body. The spinal spacer can include a plurality ofsubstantially L-shaped fluid passages that can be defined by thesubstantially annular body and can connect the plurality of outerapertures to the plurality of inner apertures, where the plurality offluid passages can be configured such that a fluid can communicate fromthe plurality of outer passages, through the plurality of fluidpassages, and into the internal cavity of the substantially annularbody. The spinal spacer can include at least one bone screw that can beconfigured to attach the substantially annular body to an anatomicalstructure. The spinal spacer can include an instrument conduit that canbe defined by the substantially annular body, where the instrumentconduit can extend from the inner surface to the outer surface of thesubstantially annular body, where the instrument conduit can beconfigured to accept a suction device such that a partial vacuum can bepresent within the internal cavity of the substantially annular body toactively draw the fluid through the plurality of fluid passages.

Embodiments of an interbody spacer can include an intervertebral spinalspacer that can include a substantially annular body having an uppersurface, a lower surface, an outer surface, and an inner surface, wherethe inner surface of the substantially annular body can define aninternal cavity. The spinal spacer can include means for drawing fluidinto the internal cavity of the substantially annular body and means forattaching the substantially annular body to an anatomical structure.

Embodiments can include an interbody spacer that can include an annularbody that can define an internal cavity and a fluid passage, where theannular body can include a first end surface configured for fixation tobone and a second end surface configured for fixation to bone, where theinternal cavity can be substantially oriented about a vertical axis. Thefluid passage can include a first aperture associated with the first endsurface and a second aperture associated with the internal cavity.

Embodiments of an interbody spacer can include an annular body that caninclude an internal cavity and a fluid passage, where the annular bodycan include a first end surface configured for fixation to bone and asecond end surface configured for fixation to bone, where the fluidpassage can have a first boundary portion associated with the first endsurface and can have a second boundary portion within the internalcavity.

An interbody spacer can include an annular body having an internalcavity, where the annular body can extend from a first end surfaceadapted for fixation to bone to a second end surface configured forfixation to bone, where the annular body can have a fluid passage thatcan have a first boundary portion associated with the first end surfaceand a second boundary portion that can be associated with the internalcavity.

Embodiments can include an interbody spacer that can include an annularbody that can define an internal cavity and a fluid passage, where theannular body can include a first end surface configured for fixation tobone and a second end surface configured for fixation to bone, where thefluid passage can include a first aperture associated with the first endsurface and a second aperture associated with the internal cavity.

BRIEF DESCRIPTION OF THE DRAWINGS

It is believed that certain embodiments will be better understood fromthe following description taken in conjunction with the accompanyingdrawings in which:

FIG. 1A is a top perspective view depicting an interbody spacer inaccordance with one embodiment;

FIG. 1B is a right side cross-sectional view of the interbody spacer ofFIG. 1A taken along A-A.

FIG. 2A is a top perspective view depicting an interbody spacer inaccordance with another embodiment;

FIG. 2B is side cross-sectional view of the interbody spacer of FIG. 2Ataken along B-B.

FIG. 3A is a top perspective view depicting an interbody spacer inaccordance with another embodiment;

FIG. 3B is side cross-sectional view of the interbody spacer of FIG. 3Ataken along C-C.

FIG. 4A is a top perspective view depicting an interbody spacer inaccordance with another embodiment;

FIG. 4B is side cross-sectional view of the interbody spacer of FIG. 4Ataken along D-D.

FIG. 5A is a top perspective view depicting an interbody spacer inaccordance with another embodiment;

FIG. 5B is side cross-sectional view of the interbody spacer of FIG. 5Ataken along E-E.

FIG. 6A is a top perspective view depicting an interbody spacer inaccordance with another embodiment;

FIG. 6B is side cross-sectional view of the interbody spacer of FIG. 5Ataken along F-F.

FIG. 7 is a top perspective view depicting an interbody spacer inaccordance with another embodiment;

FIG. 8 is a top perspective view depicting an interbody spacer inaccordance with another embodiment;

FIG. 9 is a top perspective view depicting a modular interbody spacer inaccordance with one embodiment;

FIG. 10 is a top perspective view depicting a modular interbody spacerin accordance with another embodiment;

FIG. 11A is a top perspective view depicting a modular interbody spacerin accordance with another embodiment;

FIG. 11B is a right side cross-sectional view of the modular interbodyspacer of FIG. 11A in accordance with another embodiment;

FIG. 12 is a top perspective view depicting a modular interbody spacerin accordance with another embodiment, where the modular spacer is shownwith a plurality of bone screws;

FIG. 13A is a top perspective view depicting a bone screw having alocking ring shown in an unsecured position; and

FIG. 13B is a top perspective view of the bone screw of FIG. 13A shownwith the locking ring in a secured position.

DETAILED DESCRIPTION

Embodiments herein describe an interbody spacer and methods for fixationof adjacent bone segments. Versions of the interbody spacer can beconfigured with fluid passages for the delivery of beneficial substancesexternal to the interbody spacer including endogenous and exogenoushematopoietic and/or growth factors to, for example, an internal cavitythat can be filled with bone graft materials, autogenous bone, allograftbone, or bone graft substitutes (such as collagen based products,demineralized bone graft products, and organic or inorganic mixturessuch as tricalcium phosphate and hyaluronic acid).

Anterior and anterolateral approaches to the lumbar spine can allow forsuperior structural support and improved ability to restore lumbarsagittal plane balance. Approximately, eighty percent of the axial loadof the spine is located in the anterior column, or along the axis of thevertebral bodies. The most robust interbody implant can be one that hasthe largest footprint on the vertebrae or across the joint spaces.Anterior and lateral based spinal fusion implants can allow for morecomplete discectomy than posterior lumbar interbody fusion (PLIF)approaches, and can allow for larger footprint interbody structuraldevices (e.g., fusion cages) with larger cavities for bone graft or bonegraft substitutes. The larger footprint can provide greater surface areafor boney fusion to occur, can offer greater structural stability, andcan minimize the risk of subsidence of the implant into the vertebralendplates.

Fixation of adjacent bone segments can be used to treat disorders of themusculoskeletal system caused by disease or trauma. In particular, bonecan be “fused” together through the growth, repair, or replacement ofbone. Example disorders include, long bone fracture, sacroiliac jointdisease, and spinal disorders, such as, degenerative disc disease,spondylolisthesis, and scoliosis. It is contemplated that versions ofspacers disclosed herein may be used with any suitable anatomicalstructure including between two joints, vertebrae, or boney surfacessuch that, for example, long bone non-unions and sacroiliac jointdisease. Fenestrations are designed to facilitate the passive,positive-pressure, and/or vacuum-assisted delivery of autogenous blood,mesenchymal cells or those of a non-differentiated pluripotentiallineage (whether autogenous, allogenic, or recombinantly derived), stemcell delivery, or delivery of growth factors.

Arranging fluid passages to transfer beneficial blood and cellularelements from the bony interfaces of bone segments into a central cavitywithin the interbody spacer can facilitate fusion. In one version, thecentral cavity of the interbody spacer can be filled with bone graftmaterial. The transferred blood and cellular elements can be beneficialto bone growth and eventual fusion of bony segments. Such beneficialsubstances can include osteoprogenitor cells, known to be beneficial tobone growth. As an example, an interbody spacer can be used for spinalfusion, a treatment where adjacent vertebras are fused together.

More specifically, the fluid passages of the interbody spacer, which canbe in direct interface with bone tissue, can include channels, conduits,fenestrations, hollow or cutting keels, or the like, can allow for thepassive flow of autogenous bone marrow, blood, cells or growth factors,and can act to transport, for example, mesenchymal stem cells,osteoprogenitor cells, or undifferentiated pluripotential cells into thecavity of an interbody spacer where they can integrate with other bonegraft materials. These fluid passages in the interbody spacer can alsobe used to actively draw blood and cellular elements via vacuum orsuction when, for example, a syringe or other instrument is attached tothe interbody spacer.

FIG. 1A shows a top perspective view of one version of an interbodyspacer 100. FIG. 1B is a cross-sectional view of the interbody spacer ofFIG. 1A taken along A-A. Interbody spacer 100 can include a body 120having an annular shape with respect to a longitudinal axis 110. Body120 can include a first end surface 122, second end surface 124, innersurface 126, and outer surface 128. First end surface 122 and second endsurface 124 can be configured for mechanical or chemical fixation tobone, such as a vertebra. The annular shape of body 120 can establish aninternal cavity 130 that can be at least partially defined by innersurface 126. A fluid passage 140 can include a first aperture 142associated with first end surface 122 and a second aperture 144associated with inner surface 126 and internal cavity 130.

It will be appreciated that the interbody spacer 100 can include avertical axis, as illustrated in FIG. 1A, where the internal cavity 130can be substantially oriented about the vertical axis such that theinternal cavity 130 is substantially open at the first end surface 122and the second end surface 124. Such a configuration may be animprovement over existing fusion cages or fusion baskets, which aregenerally annular devices having a central cavity oriented about an axisthat is perpendicular to the vertical axis shown in FIG. 1A. Fusioncages are generally annular tubes that have a relatively small surfacearea for bone attachment and this surface area is also generally curvedor arcuate. Embodiments of spacers described herein may improve boneattachment by providing a substantially flat or planar surface and agreater surface area relative to existing fusion cages for bonefixation. Orienting the body 120 of the spacer 100 vertically such thatthe spacer 100 is substantially parallel to vertebrae may also improvestability. It will be appreciated that spacers in accordance withembodiments described herein can be implanted posteriorly.

In one version, interbody spacer 100 can be suitably sized for spinalfusion. Interbody spacer 100 can be positioned in the intervertebraldisc space between adjacent vertebral bodies (not shown). Interbodyspacer 100 can further be configured for the cervical spine andimplanted using an anterior surgical approach, as an example. Annularbody 120 can maintain the desired spacing between the vertebral bodiesand can support physiologic loading. Internal cavity 130 can be filledwith bone graft or other materials suitable to promote bony fusion.Endplates of adjacent vertebral bodies can be prepared for the interbodyspacer 100, which can produce advantageous “bleeding bone”, a conditionthat can be advantageous to stimulate bone growth and promote spinalfusion. In one version, cavity 130 can be an open structure, wherematerials within the cavity, such as bone graft, can be in contact withthe bleeding bone. Annular body 120 can include one or a plurality offluid passages 140. As better illustrated in FIG. 1B, fluid passages 140are arcuate, but can be any suitable shape and can define straight holesor apertures of any suitable configuration.

First end surface 122 and second end surface 124 can be placed incontact with the vertebral endplates such that blood constituents andbone marrow constituents can be delivered into the first aperture 142,communicate through the fluid passages 140, and flow out of secondaperture 144 into the internal cavity 130. The first aperture 142 can beany hole, space, fenestration, or passage that can be located on asurface that interfaces directly or substantially directly with bone.The second aperture 144 can be any hole, space, fenestration, or passagethat can interface directly or substantially directly with the internalcavity or the inner surface of the annular body. For example, the firstaperture 142 can be positioned adjacent a vertebral endplate and can beconfigured to receive a fluid, where the fluid can be communicated viathe second aperture 144 into the internal cavity of the annular body. Inan example embodiment, the first aperture 142 is substantiallyperpendicular to the second aperture 144. The fluid passages can haveany suitable shape, such as an L-shape, to facilitate fluidcommunication from a region adjacent a bone into the internal cavity ofan annular body. The fluid passages can be non-vertical, non-linear,curved, arcuate, of uniform diameter, of varying diameter, or canotherwise be suitably shaped. It will be appreciated that any suitablenumber of fluid passages, including fluid passages having differentshapes, sizes, or purposes, is contemplated. Beneficial constituentswithin blood and bone marrow can include a variety of growth factors andcells, such as osteoprogenitor cells. In combination with bone graft,bone graft substitute materials, or other materials within internalcavity 130, the blood and cellular elements delivered through fluidpassages 140 can promote bone growth and eventual bony fusion.

Fluid passages 140 can also be used to actively draw blood and cellularelements into the internal cavity 130 by applying a negative pressure.Referring again to FIGS. 1A and 1B, radial passage 170 can be a conduit(e.g., an instrument conduit) having outer aperture 172 in associationwith outer surface 128 and inner aperture 174 in association with innersurface 126. Radial passage 170 can be configured for the selectiveattachment of a surgical instrument (not shown) that can be used toinsert and position interbody spacer 100 between bone segments,including vertebral bodies. With respect to anatomical positioning,radial passage 170 can be associated with the anterior, posterior, orlateral aspect of the device relative to the patient's anatomy, asexamples. Radial passage 170 can be configured for use with a suctiondevice, such as a syringe, to create at least a partial vacuum withininternal cavity 130 such that blood and cellular elements can be drawndirectly into internal cavity 130 or through fluid passages 140. Radialpassage 170 can be used to transfer substances into the internal cavity130 via a syringe or one or a plurality of other instruments suitablefor dispensing materials to promote bone growth or for any othersuitable purpose.

The one or a plurality of fluid passages can vary in shape ofcross-section. As an example, FIG. 2A shows a top perspective view ofone version of an interbody spacer 200. FIG. 2B is a cross-section viewtaken along B-B. Interbody spacer 200 can include a body 220 that canhave an annular shape with respect to longitudinal axis 210. Body 220can include a first end surface 222, a second end surface 224, an innersurface 226, and an outer surface 228. First end surface 222 and secondend surface 224 can be configured for fixation to bone. The annularshape of body 220 can establish an internal cavity 230 that can bepartially defined by inner surface 226. Fluid passage 240 can include afirst aperture 242 that can be associated with first end surface 222 anda second aperture 244 that can be associated with inner surface 226. Asan example, fluid passage 240 can be associated with a conical portion246 such that first aperture 242 has a greater diameter relative tosecond aperture 244. Working like a funnel, first aperture 242 andconical portion 246 of fluid passage 240 can expose more surface area ofprepared bone and can increase the potential area for blood and cellularelements to flow into internal cavity 230.

Bony interface surfaces can be configured for fixation to bone and caninclude features that can mechanically interlock into bone.Specifically, bony interface surfaces can feature protrusions in theform of a keel, spike, or saw-tooth serration, as examples. Theseprotrusions or surface effects can be singular or patterned, where in apatterned configuration the protrusions can be, for example, raisedareas that can form a serration. As an example, interbody spacers ordevices for anterior spinal fusion can include a keel that can bealigned with the anterior-posterior direction and can form an attachmentsurface with a protrusion. As another example, an interbody spacer forspinal fusion can include a saw-tooth design aligned with themedial-lateral direction in the form of serration. A multitude ofconical or pointed protrusions (spikes) can be arranged on a bonyinterface surface. A fluid passage can be integral with or associatedwith any of these protrusions. In one version, an opening of a fluidpassage can be configured near or at the peak of a protrusion, such thatthe opening of the fluid passage can be nearer or embedded deeper intobone.

One version of an interbody spacer 300 is shown in FIG. 3A and FIG. 3B.Interbody spacer 300 can include a body 320 having an annular shape withrespect to a longitudinal axis 310. Body 320 can include a first endsurface 322, a second end surface 324, an inner surface 326, and anouter surface 328. First end surface 322 and second end surface 324 canbe configured for fixation to bone. The annular shape of body 320 canestablish an internal cavity 330 that can be partially defined by innersurface 326. First end surface 322 can include a plurality of conicalprotrusions 348. Fluid passage 340 can include a first aperture 342 thatcan be associated with first end surface 322, located at the apex ofconical protrusion 348. Second aperture 344 can be associated with innersurface 326 and internal cavity 330.

Previously discussed embodiments feature closed fluid passages, but openfluid passages can also be incorporated to transfer blood and cellularelements into an internal cavity. In addition, the internal cavity canhave any suitable volume, such as a volume greater than the cavitiesshown, such that additional bone graft material can be used. Theinternal cavity can include a relatively large opening at the boneinterface, which can facilitate maximum contact with surgically preparedbone, which can include bone scraped or otherwise cut or treated toallow blood and cellular elements to integrate with bone graft materialwithin an interbody spacer. Fluid passages can be configured to increasethe volume of a cavity and can increase the contact area for bone graftmaterials and prepared bone, such as bleeding bone.

FIG. 4A shows a top perspective view of one version of an interbodyspacer 400. FIG. 4B is a cross-section view taken along D-D. Interbodyspacer 400 can include a body 420 that can have an annular shape withrespect to a longitudinal axis 410. Body 420 can include a first endsurface 422, a second end surface 424, an inner surface 426, and anouter surface 428. First end surface 422 and second end surface 424 canbe configured for fixation to bone. Fluid passage 440 can include afirst boundary 442 associated with first end surface 422 and a secondboundary 444 associated with inner surface 426. The annular shape ofbody 420 can establish an internal cavity 430 that can be partiallydefined by inner surface 426 and fluid passages 440. Fluid passage 440can include one or a plurality of open passages or recessed portions,which can expand internal cavity 430 at the juncture between the firstend surface 422 and inner surface 426.

Interbody spacer 500, shown in FIG. 5A and FIG. 5B, can include a body520 that can have an annular shape with respect to a longitudinal axis510. Body 520 can include a first end surface 522, a second surface 524,an inner surface 526, and an outer surface 528. First end surface 522and second end surface 524 can be configured for fixation to bone. Theannular shape of body 520 can establish an internal cavity 530 that canbe partially defined by inner surface 526 and fluid passage 540. Fluidpassage 540, can be in the form of a chamfer, and can include a firstboundary 542 associated with a first end surface 522 and a secondboundary 544 at the juncture with inner surface 526. First boundary 542can be proximate to outer surface 528 and can increase the volume ofinternal cavity 530 and can enlarge internal cavity 530 at a bonyinterface. Alternatively, first boundary 542 can be centrally locatedbetween inner surface 526 and outer surface 528. Inner surface 526 andfluid passages 540 can result in cavity 530 having a generally hourglassshape, wherein internal cavity 530 can be wider at its ends.

Interbody spacer 600, shown in FIG. 6A and FIG. 6B, can include a body620 that can have an annular shape with respect to a longitudinal axis610. Body 620 can include a first end surface 622, a second end surface624, an inner surface 626, and an outer surface 628. First end surface622 and second end surface 624 can be configured for fixation to bone.The annular shape of body 620 can establish an internal cavity 630 thatcan be partially defined by inner surface 626 and fluid passage 640.Fluid passage 640, which can have a round form, can include a firstboundary 642 associated with a first end surface 622 and a secondboundary 644 at the juncture with inner surface 626. First boundary 642can be proximate to outer surface 628 and can increase the volume ofinternal cavity 630 and can enlarge internal cavity 630 at a bonyinterface. Alternatively, first boundary 642 can be centrally locatedbetween inner surface 626 and outer surface 628. Inner surface 626 andfluid passages 640 can result in internal cavity having a generallyhourglass shape, wherein internal cavity 630 can be wider at its ends.

Fluid passages intended for the flow of blood and other fluidconstituents can be combined with bony interface surfaces to form aserrated surface that can enhance attachment to bone. This can beaccomplished by fluid passages that are open cross-sections, closedcross-sections, or combinations thereof. As an example, interbody spacer700 of FIG. 7 can include a body 720 that can include an annular shape,a first end surface 722, a second surface 724, an inner surface 726, anouter surface 728, an inner chamfer 752, and an outer chamfer 754. Firstend surface 722, which can be configured for fixation to bone, caninclude an internal chamfer 752, an outer chamfer 754, and an exemplarypeak 750. The annular shape of body 720 can establish an internal cavity730 that can be partially defined by inner surface 726 and internalchamfer 752. Fluid passage 740 can include a hole or aperture with agenerally circular cross-section. The ends of fluid passage 740 can bedefined by first boundary 742 associated with first end surface 722 andsecond boundary 744 at the juncture with inner surface 726. A pluralityof fluid passages 740 intersecting first end surface 722 can define aplurality of peaks 750 and can form a serration that can enhancefixation of the interbody spacer 700 to bone.

Interbody spacer 800, shown in FIG. 8 , can include a body 820 that canhave an annular shape. Body 820 can include a first end surface 822, asecond end surface 824, an inner surface 826, and an outer surface 828.First end surface 822 and second end surface 824 can be configured forfixation to bone. The annular shape of body 820 can establish aninternal cavity 830 that can have a boundary partially defined by innersurface 826. Fluid passages 840 can include a first boundary 842associated with the juncture of first end surface 822 and outer surface828. Second boundary 844 can be associated with inner surface 826 andinternal cavity 830. Fluid passage 840 can follow an arcuate pathdirected toward the central region of internal cavity 830. The annularshape of body 820 can establish an internal cavity 830 that can bepartially defined by inner surface 826. Fluid passage 840 can bepatterned to form peak 850, further defining a serration that canenhance fixation to bone.

A surgeon can have an initial implant strategy and implant systemprepared for a patient, but conditions discovered or occurringintraoperatively can result in the desire to have a different implantsystem. One version of an interbody spacer system can includeinterchangeable elements to provide for variations in anatomical size orshape and can allow for a more tailored fit with respect to theanterior-posterior plane of the intervertebral space, and the optionaluse of supplementary fixation elements. Various fixations elements canbe useful to achieve desired levels of fixation and stability.Accordingly, an interbody spacer system can be configured as a modularinterbody spacer, where the modular interbody spacer can includefixation elements that can maintain implant position (e.g., aninterference screw). A modular interbody spacer can include fixationelements that can provide additional stability to targeted bonesegments.

The width-to-depth ratio of the lumbar vertebrae can vary betweenpatients. Existing implant systems typically allow for small/medium andlarge/extra-large cages with fixed ratios of lateral andanterior-posterior sizing. Often, either the anterior-posterior depth,or the inability to gain extensile exposure of the anterior vessels canforce the surgeon to select a smaller side-to-side dimensioned cage tosafely insert it into the intradiscal space. The smaller side-to-sidecages can lack the appropriate anterior-posterior depth to optimizefusion surface area.

A modular interbody spacer system and method can include, for example,the following, (1) selecting a first component for insertion into anintervertebral disc space, (2) selecting and using a second componentfor interconnection with the first component, and (3) selecting afixation element. The second component can have attributes that cancontribute to the size and shape of the interbody spacer system and caninclude holes or other features that can enable the attachment offixation elements, such as screws.

FIG. 9 shows one embodiment of a modular interbody spacer 1100 that canbe configured for fixation of adjacent bone segments. Modular body 1120can include a first component 1162 and a second component 1164. Firstcomponent 1162 can be associated with one of more internal cavities,such as internal cavity 1132 and second component 1164 can include aninternal cavity 1134. As described herein, internal cavities can befilled with bone graft or other materials that can promote bone growthand fusion. The bony interfaces of modular body 1120 can be furtheradapted with spikes, keels, or porous coatings, as examples, that canfacilitate attachment to bone. First component 1162 and second component1164 can be arranged in an interlocking manner. As shown, modularinterbody spacer 1100 can be configured without modular, orsupplementary fixation elements (e.g., bone screws). Second component1164 is shown by way of example, where alternative components can becombined with first component 1162 in a modular manner. It will beappreciated that first component 1162, for example, can be usedindependently of second component 1164, where the second component 1164can be a selectively usable option. These alternative components mayhave various shapes and features to facilitate the use of additionalfixation components, such as bone screws, adhesives, screws, pins, orthe like. It will be appreciated that any suitable number of components,of any size, shape, or function, can be provided or otherwise make upthe modular interbody spacer 1100. Although not shown in FIG. 9 firstcomponent 1162 can be configured with fluid passages for the flow ofblood into internal cavities, as described in certain other embodiments(see for example FIGS. 1A, 2A, 3A, 4A, 5A, 6A, 7 and 8 ). These fluidpassages can be designed to facilitate the passive, positive-pressure,and/or vacuum-assisted delivery of autogenous blood, mesenchymal cellsor those of a non-differentiated pluripotential lineage (whetherautogenous, allogenic, or recombinantly derived), stem cell delivery, ordelivery of growth factors.

FIG. 10 shows one version of an interbody spacer 1200 that can beconfigured for fixation of adjacent bone segments. Modular body 1220 caninclude a first component 1262 and a second component 1264. Firstcomponent 1262 can be associated with internal cavity 1232 and secondcomponent 1264 can include an internal cavity 1234. The bony interfacesof modular body 1220 can be configured with spikes, keels, or porouscoatings, as examples, that can facilitate attachment to bone. Firstcomponent 1262 and second component 1264 can be arranged in aninterlocking manner or in any other suitable manner such as a snap fit,a tongue and groove, an adhesive, a threaded connection, or the like. Asshown, interbody spacer 1200 can be configured without modular, orsupplementary fixation elements (e.g., bone screws). Second component1264 can be combined with first component 1262 in a modular manner.Although not shown in FIG. 10 first component 1262 and second component1264 can be configured with fluid passages for the flow of blood intointernal cavities, as described in certain other embodiments (see forexample FIGS. 1A, 2A, 3A, 4A, 5A, 6A, 7 and 8 ).

FIG. 11A shows one version of an interbody spacer 1300 that can beconfigured for fixation of adjacent bone segments. Modular body 1320 caninclude a first component 1362 and a second component 1364. Firstcomponent 1362 can be associated with internal cavity 1332. The bonyinterfaces of modular body 1320 can be further configured with spikes,keels, or porous coatings, as examples, that can facilitate attachmentto bone. First component 1362 and second component 1364 can be arrangedin an interlocking manner. As shown, interbody spacer 1300 can beconfigured without modular, or supplementary fixation elements (e.g.,bone screws). Second component 1364 can be combined with first component1362 in a modular manner, or with any other suitable component. Thesealternative components can have various shapes and features tofacilitate the use of additional fixation components, such as, bonescrews. At least a portion of second component 1364 can be external tothe space between bone fragments to facilitate the placement of bonescrews on the outside of bone segments. As shown in FIG. 11B, firstcomponent 1362 (base component) can be configured with fluid passages1340 including a first aperture 1342 and a second aperture 1344 for theflow of blood into internal cavity 1332, as described in certain otherembodiments (see for example FIGS. 1A, 2A, 3A, 4A, 5A, 6A, 7 and 8 ).

Additionally, a second component of an interbody spacer for spinalfusion may allow surgeons to perform the anterior lumbar interbodyfusion (ALIF) without the need for additional components, such as,posterior pedicle screws inserted through a second surgical site. FIG.12 shows one version of an interbody spacer 1400 that can be configuredfor fixation of adjacent bone segments. Modular body 1420 can include afirst component 1462 and a second component 1464. First component 1462can be associated with internal cavity 1432. The bony interfaces ofmodular body 1420 can be configured with spikes, keels, or porouscoatings, as examples, that can facilitate attachment to bone. Firstcomponent 1462 and second component 1464 can be arranged in aninterlocking manner. As shown, interbody spacer 1400 can be configuredwith modular, or supplementary fixation elements (e.g., bone screws).Second component 1464 can be configured with holes 1463 (see FIG. 12 )that can facilitate the placement of bone screws 1480. Bone screws 1480can be provided to keep interbody spacer system 1400 in a desiredlocation and can provide additional stability to bone structures.Fixation screws can also be configured to secure first component 1462 tosecond component 1464. Fixation screws can be 4 total for this optionand can be divergent in the cephalad-caudad anatomic plane and/or in thelateral or side-to-side anatomic plane, not convergent or parallel. Thisconfiguration may increase rigidity in torsion, flexion, extension andlateral bending, as well as reduce the risk of implant displacement. Asan example, bone screws 1480 can be secured into vertebral bodies.Additionally, an anterior metallic plate can be incorporated to allowthe metallic screws to lock more securely to the anterior module; incases where nonmetallic screws (ceramic, PEEK, or other material) may beused, the plate can match the material of the screws. A separate modularplate can allow the screws to lock in a metal to metal fashion, orsimply lock to the actual cage itself.

The concept of modularity of the ALIF can provide multiple advantages.From an inventory standpoint, cages can be built up to patient-specificsizing in a stacking fashion such that, for example, two or threestandard size base units can be used to create a plurality ofconfigurations. If additional depth is needed, for example, a small (2mm), medium (4 mm), or deep (6 mm) add-on component piece can be coupledwith and locked to the base unit cage. A screw hole to provisionally fixto the vertebral bodies can also be designed to help lock the stackableunits into place. This can allow for anterior-posterior fusions and canallow for the patient to be turned from supine (anterior fusion) toprone (posterior fusion) without risk of the ALIF displacing during theturning of the patient from supine to prone. Such a system can alsoallow for surgeons who stage their anterior and posterior proceduresacross several days to safely allow patients to be ambulatory ratherthan keeping them on bedrest between the anterior and posterior stagesof the fusion.

It can also be advantageous to provide a mechanism for securing a bonescrew to an interbody device, such that component parts can be resistantto separation if components loosen during the course of healing. Relatedto the ability to sterilize and clean components, it can be desirable tohave implant components loosely preassembled. FIGS. 13A and 13B show oneversion of a bone screw 1480 of FIG. 12 that can include screw body 1485and a locking ring 1490. Screw body 1485 can include a tapered head1487, a head recess 1486, and a thread 1488. Locking ring 1490 can havean annular shape and can include a split 1492 to allow for expansion.Upon securing bone screw 1480 within hole 1463 of interbody spacer 1400(see FIG. 12 ), locking ring 1490 can slide and expands along taperedhead 1487, and can be finally secured in an expanded form within headrecess 1486, as shown in FIG. 13B. Hole 1463 can be suitably shaped toforce locking ring 1490 to slide along tapered head 1487. Hole 1463 canalso be suitably shaped or recessed to secure screw 1480, such that thecomponents are resistant to separation. Any configuration or number ofscrews, locking rings, or the like is contemplated.

All interbody spacers and interbody spacer systems shown may provide“zero profile” or very low profile fixation. As an example of zeroprofile fixation in spinal fusion, the entirety of the implant can bewithin the intervertebral disc space to avoid contact with anteriorgreat vessels that run along the front of the spine (inferior vena cava,aorta, iliac veins and arteries). A very low profile configuration canallow part of the implant to perch on the anterior lip of the vertebralbody for stability purposes. Materials for the interbody spacer bodiesinclude a variety of structural biomaterials, for example, such astitanium alloy, PEEK, allograft bone, or ceramic, such as siliconnitride, as examples.

In various embodiments disclosed herein, a single component can bereplaced by multiple components and multiple components can be replacedby a single component to perform a given function or functions. Exceptwhere such substitution would not be operative, such substitution iswithin the intended scope of the embodiments.

The examples discussed herein are examples only and are provided toassist in the explanation of the apparatuses, devices, systems andmethods described herein. None of the features or components shown inthe drawings or discussed below should be taken as mandatory for anyspecific implementation of any of these the apparatuses, devices,systems or methods unless specifically designated as mandatory. For easeof reading and clarity, certain components, modules, or methods may bedescribed solely in connection with a specific figure. Any failure tospecifically describe a combination or sub-combination of componentsshould not be understood as an indication that any combination orsub-combination is not possible. Also, for any methods described,regardless of whether the method is described in conjunction with a flowdiagram, it should be understood that unless otherwise specified orrequired by context, any explicit or implicit ordering of stepsperformed in the execution of a method does not imply that those stepsmust be performed in the order presented but instead may be performed ina different order or in parallel.

The foregoing description of embodiments and examples has been presentedfor purposes of illustration and description. It is not intended to beexhaustive or limiting to the forms described. Numerous modificationsare possible in light of the above teachings. Some of thosemodifications have been discussed, and others will be understood bythose skilled in the art. The embodiments were chosen and described inorder to best illustrate principles of various embodiments as are suitedto particular uses contemplated. The scope is, of course, not limited tothe examples set forth herein, but can be employed in any number ofapplications and equivalent devices by those of ordinary skill in theart. Rather it is hereby intended the scope of the invention to bedefined by the claims appended hereto.

What is claimed is:
 1. An intervertebral spinal spacer comprising: (a) afirst portion of a modular spacer, the first portion having an uppersurface, a lower surface, and an outer surface; and (b) a second portionof the modular spacer, the second portion having an upper surface alower surface, and an outer surface, wherein the first portion isselectively engageable with the second portion, wherein at least one ofthe first portion or the second portion includes a plurality of outerapertures.
 2. The intervertebral spinal spacer of claim 1, wherein thefirst portion and the second portion each define an internal cavityextending from the respective upper surface to the respective lowersurface.
 3. The intervertebral spinal spacer of claim 2, wherein thefirst portion or the second portion includes a plurality of innerapertures, the plurality of inner apertures being defined by an innersurface of an internal cavity defined by the modular spacer.
 4. Theintervertebral spinal spacer of claim 3, further comprising a pluralityof fluid passages defined by the modular spacer and connecting eachrespective outer aperture to a corresponding inner aperture such thatfluid communicates from the plurality of outer apertures, through theplurality of fluid passages, and into the internal cavity defined by themodular spacer.
 5. The intervertebral spinal spacer of claim 1, furthercomprising an instrument conduit, wherein the instrument conduit is apassageway defined by the at least one of the first portion or thesecond portion.
 6. The intervertebral spinal spacer of claim 5, whereinthe instrument conduit is sized to receive a suction device.
 7. Theintervertebral spinal spacer of claim 1, wherein the first portion isoperably configured to mate with the second portion such that acustomized modular spacer is formed.
 8. The intervertebral spinal spacerof claim 1, further comprising at least one fastener to attach themodular spacer to an anatomical structure.
 9. The intervertebral spinalspacer of claim 1, wherein the upper surface or the lower surface of thefirst portion or the second portion includes an interface thatfacilitates attachment to bone.
 10. The intervertebral spinal spacer ofclaim 1, wherein the modular spacer provides zero profile spinal fusion.11. The intervertebral spinal spacer of claim 1, wherein the firstportion of the modular spacer is selectable from a plurality of sizeshaving different widths such that the first portion is customizable to apatient's anatomy.
 12. The intervertebral spinal spacer of claim 11,wherein the second portion of the modular spacer is selectable from aplurality of sizes having different depths such that the second portionis customizable to the patient's anatomy.
 13. The intervertebral spinalspacer of claim 1, where in the first portion includes a firstattachment member and the second portion includes a second attachmentmember such that the first portion and the second portion areinterlocked.
 14. The intervertebral spinal spacer of claim 1, whereinthe first portion and the second portion each define an internal cavityextending from the respective upper surface to the respective lowersurface, and wherein the intervertebral spinal spacer further comprises:at least one fluid passage defined by the first portion or the secondportion, the at least one fluid passage being in fluid communicationwith at least one of the internal cavities, wherein each of the internalcavities has a sidewall extending between an upper opening on therespective upper surface and a lower opening on the respective lowersurface of the first portion or the second portion defining the internalcavity, and wherein the at least one fluid passage extends between aninner aperture on the sidewall and an outer aperture on the respectiveupper surface of the first portion or the second portion.
 15. Anintervertebral spinal spacer comprising: (a) a first portion of amodular spacer, the first portion being selectable from a plurality ofspacer elements having different sizes, the first portion having anupper surface, a lower surface, an outer surface, and a first attachmentmember; and (b) a second portion of the modular spacer, the secondportion being selectable from the plurality of spacer elements havingdifferent sizes, the second portion having an upper surface a lowersurface, an outer surface, and a second attachment member, wherein thefirst attachment member is engaged with the second attachment member tointerlock the first portion and the second portion, and wherein at leastone of the first portion or the second portion includes a plurality ofouter apertures.
 16. The intervertebral spinal spacer of claim 15,wherein the first portion and the second portion each define an internalcavity extending from the respective upper surface to the respectivelower surface.
 17. The intervertebral spinal spacer of claim 15, whereinthe first portion of the modular spacer is selectable from a pluralityof sizes having different widths, and wherein the second portion of themodular spacer is selectable from a plurality of sizes having differentdepths.
 18. The intervertebral spinal spacer of claim 15, furthercomprising a third portion of the modular spacer being selectable fromthe plurality of spacer elements having different sizes for attachmentto the modular spacer.
 19. A kit for an intervertebral spacercomprising: (a) a plurality of anterior portions for a modular spacer,each of the plurality of anterior portions for the modular spacer havinga different size; and (b) a plurality of posterior portions for amodular spacer, each of the plurality of posterior portions for themodular spacer having a different size; wherein at least one of theplurality of anterior portions is interlocked with at least one of theplurality of posterior portions, and wherein each of the plurality ofanterior portions or each of the plurality of posterior portions includea plurality of outer apertures.
 20. The kit for an intervertebral spacerof claim 19, wherein each of the plurality of anterior portions has adifferent width and each of the plurality of posterior portions has adifferent depth.